FDA.reportPublic FDA data

Trophon EPR

Primary DI
09350855000009
Brand
Trophon EPR
Company
NANOSONICS LIMITED
Model
N00010-US
Device description
Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, MistRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103059000TROPHONNanosonics Limited2011-02-24OUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000108PackageGS11In Commercial Distribution
09350855000009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000108093508550001089350855000108
09350855000009093508550000099350855000009

GMDN Terms#

Term, Definition table
TermDefinition
Atomized-chemical device disinfectorAn electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet (e.g., with internal shelves) intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.

Regulatory Flags#

DUNS number
741021943
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20
09350855000900CORIS Smart Seal BN055242026-05-20
09350855000993CORIS Device BodyN055152026-05-20
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000146trophon Sonex-HLN05002N05002-12PK2018-06-15
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000573trophon Wireless Ultrasound Probe HolderN05030-USN05030-US2024-10-25
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09350855001037trophon2 RefurbishedNANOSONICS LIMITEDOUJ2025-11-01
09350855000740trophon3NANOSONICS LIMITEDOUJ2025-08-14
09350855000573trophon Wireless Ultrasound Probe HolderNANOSONICS LIMITEDOUJ2024-10-25
09350855000559trophon Curved Probe PositionerNANOSONICS LIMITEDOUJ2022-07-08
09350855000566trophon Curved Probe PositionerNANOSONICS LIMITEDOUJ2022-07-08
09350855000146trophon Sonex-HLNANOSONICS LIMITEDOUJ2018-06-15
09350855000184trophon2NANOSONICS LIMITEDOUJ2018-06-15
09350855000160trophon Sonex-HLNANOSONICS LIMITEDOUJ2018-06-15
09350855000016Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000023Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000030Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000122Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000108Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000115Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000092Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000139Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000078Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21